Regulatory Affairs Specialist

Updated: April 12, 2024 04:20 AM GMT

Nikkiso Europe GmbH

Langenhagen

Nikkiso is leading global medical technology company specialized in the development, manufacturing and distribution of Pharmaceutical and Medical device products for the treatment of acute and chronic kidney failure and other extra-corporeal blood treatments.

Nikkiso is opening a permanent full-time position for a Regulatory Affairs Specialist.

If this opportunity is of interest to you, please join to your application a Resumé/CV together with a cover letter.

Essential duties and responsibilities
• Execute and assist Medical Device Registration for EMEA, Russia, China
• Execute and assist internal regulatory review processes for product life cycle and product development to be in compliance with the conformity assessment according to MDR
• Execute and improve internal records systems especially regulatory flies (Technical File according to MDR Annex II &III or STED)
• Execute and assist on Post Market Surveillance (PMS) activities according to MDR
• Assist in SOP development... More Detail